Ottobock 28L20 Gebrauchsanweisung Seite 5

7.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro-
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft.
Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger Verantwortung gemäß
Anhang VII der Richtlinie erstellt.
1 Application
Last update: 2015-11-26
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The 28L20 Hip Abduction Orthosis is to be used exclusively for the treatment of congenital hip
dysplasia in infants.
2 Indication and function
Treatment of hip dysplasia Type IIb (as categorized by Graf ) as well as residual dysplasia after
conservative reduction of hip dislocation
Specific indication should be determined by the prescribing physician.
This particular type of treatment (devised by Hoffman and Daimler) has been used effectively for
decades. When the child begins to stand on its own, development of the acetabulum will occur
until the child has reached the age of 18 months.
Note:
The 28L20 Hip Abduction Orthosis was designed for children being at the age of 6 to
18 months.
Note:
Please observe the indication period, since otherwise the stability of the components
and thus the security of the patient will be endangered.
3 Components
The 28L20 Hip Abduction Orthosis is available in one size and consists of the following compo-
nents (fig.1):
(1) 29L48=LI/RI Medial Condyle Band
(2) 29L48=LA/RA Lateral Condyle Band
(3) 29L51=40 Spreader Bar
(4) 29Y27=M4×6 Hexagon Head Cap Screws M4 with Collar
(5) 21Y136=38-7 Hook and Loop Strap with Roll Loop
(6) 29L56 Rubber Collar
(7) 29L103 Abduction Unit
(8) 29L50=L/R Condyle Pads
28L20
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